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Completed

NCT Number: NCT05951036

Effect of Blood Flow Restriction Training to Muscle Strength, Dynamic Stability, and ACL Injury Prevention

The goal of this randomized clinical trial study is to compare low-load blood flow restriction (LL-BFRt), sham LL-BFRt, and high-load eccentric training (HL-Et) in healthy level 1 sportsman. The main questions it aims to answer are:

1. Does LL-BFR improve muscle strength better than sham LL-BFRt and HL-Et? 2. Does LL-BFR improve dynamic stability better than sham LL-BFRt and HL-Et? 3. Does LL-BFR prevent ACL injury better than sham LL-BFRt and HL-Et?

Participants will be randomized into three intervention groups: LL-BFRt, sham LL-BFRt, and HL-Et. Participants will be asked to do:

* In LL-BFRt, participants will be asked to do LL eccentric training (including double leg squats, split squats, deadlifts, and monster walks) with a 30% of repetition maximum (RM) and 70% of arterial occlusion pressure (AOP). * In sham LL-BFRt, participants will be asked to do LL eccentric training with a 30% of repetition maximum (RM) and 10% of arterial occlusion pressure (AOP). * In HL-Et, participants will be asked to do LL eccentric training with a 70% of repetition maximum (RM).

Researchers will compare LL-BFRt, sham LL-BFRt, and HL-Et to see if muscle strength, dynamic stability, and ACL injury prevention improve after the interventions and follow-up.

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Key information

Conditions

Healthy Subjects Sports Level 1

Age range

15 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Physical therapy laboratory, College of Medicine, Universitas Udayana and ROM Physiotherapy Private Clinic Denpasar

Denpasar, Bali, 80232, Indonesia

About this study

Participants will be asked to do five sets of ten repetitions of each eccentric training, one-minute rest interval for each eccentric training and two mins rest interval between each set.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Being 15-35 years old
  • Perform sports level 1 (soccer, basket ball, futsal, combat martial art) at least twice per week.
  • Never had an history of ACL injury
  • Never had an history of sprain or strain grade III
  • Agree to participate until the end of this study period and sign the inform consent

Exclusion criteria

  • Having hypertension, blood circulation disease, anemia, obesity, diabetes, kidney failure, vena thromboembolic, cancer, and tumor.
  • Disabilities or disabled people.

Treatment and study plan

Low-load Blood Flow Restriction training

Procedure

Physical therapist will apply the BFR cuffs with 70% of arterial occlusion pressure on the both legs of participants. Then, participants will be asked to perform eccentric trainings (including, double leg squats, split squats, deadlifts, and monster walks) with 30% of repetition maximum.

Sham Low-load Blood Flow Restriction training

Procedure

Physical therapist will apply the BFR cuffs with 10% of arterial occlusion pressure on the both legs of participants. Then, participants will be asked to perform eccentric trainings (including, double leg squats, split squats, deadlifts, and monster walks) with 30% of repetition maximum.

High-load Eccentric training

Procedure

Physical therapist will ask participants to perform eccentric trainings (including, double leg squats, split squats, deadlifts, and monster walks) with 70% of repetition maximum.

Primary outcomes

  1. Muscle strength

    Time frame: 8 weeks

    Investigators will measure the quadriceps muscle isometric strength using dynamometer (units: Newton or kilogram).

  2. Dynamic stability I

    Time frame: 8 weeks

    Investigators will measure the dynamic stability I using Y-balance test (units: centimeter).

  3. Dynamic stability II

    Time frame: 8 weeks

    Investigators will measure the dynamic stability II using single leg hop test (units: centimeter).

Sponsors and collaborators

Lead sponsor

Udayana University

Other

Registry information

Official study title

Effects of Additional Blood Flow Restriction and Sham Blood Flow Restriction in Eccentric Exercise on Muscle Strength, Dynamic Stability, and Reduce the Risk of ACL Injury

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Jul 18, 2023
Registry last updated
Jun 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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